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A Study of NE3107 in Early Parkinson's

RECRUITINGPhase 2Sponsored by BioVie Inc.
Actively Recruiting
PhasePhase 2
SponsorBioVie Inc.
Started2025-03-26
Est. completion2025-12-01
Eligibility
Age45 Years – 80 Years
Healthy vol.Accepted
Locations4 sites

Summary

The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are: * Will bezisterim decrease movement symptoms of Parkinson's disease? * What medical problems do participants have when taking bezisterim? Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease. Participants will * have a physical examination that includes an electrocardiogram * take drug or placebo twice daily for four months * visit a clinical site or receive an at home visit seven times over the course of five months

Eligibility

Age: 45 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* 45 years to 80 years of age
* diagnosed with idiopathic Parkinson's Disease (PD) within 18 months
* nearing the need for symptomatic therapy
* agree to use birth control measures
* provide voluntary consent
* willing to allow blood collection for DNA methylation analysis
* pass all screening tests and procedures

Exclusion Criteria:

* has taken levodopa or another similar drug for the motor symptoms of PD
* a known or strongly suspected familial cause for PD diagnosis
* major mental health or physical illness
* medical history of major mental or physical illness

Conditions2

Parkinson's DiseaseParkinsons Disease (PD)

Locations4 sites

Michigan

1 site
Quest Research Institute
Farmington Hills, Michigan, 48334
Aaron Ellenbogen, DO, MPH

New York

1 site
Dent Neurologic
Amherst, New York, 14226
Lixin Zhang, MD, PhD

North Carolina

1 site
Science 37 (Nationwide Site)
Morrisville, North Carolina, 27560
David Kudrow, MD

Ohio

1 site
NeuroScience Research Center, LLC
Canton, Ohio, 44718
Ryan Drake, DO

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